Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)

Not Applicable

Recruiting

• Conditions: Sensorineural Hearing Loss, Bilateral; Cochlear Implants
• Interventions: Device: Post-operative ABF followed by fitting according to clinical standard; Device: Fitting according to clinical standard followed by post-operative ABF

• Registration Number: NCT05369598
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated. This study will focus on patients that are already implanted with the HEARO robotic system.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age ≥ 18 years
• Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
• Subject implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
• Subject implanted with MED-EL cochlear implant(s) with Flex28, Flex 26 or FlexSoft electrode to obtain maximum cochlear coverage
• Subject planned to receive a MED-EL SONNET 2 or RONDO 3 audio processor on the newly implanted side
• Subject is either a user with unilateral implantation, bilateral implantation or a bimodal CI user (unilateral CI user with contralateral ear adequately fitted with a hearing aid)
• Pre- operative and post-operative CT scan of the temporal bone available
• Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
• Audio processor not yet activated on the newly implanted side
• Minimum of 10 active channels can be activated
• Fluent in the language of the test centre (Dutch or French)
• Signed and dated ICF before the start of any study-specific procedure

Exclusion Criteria

• Subject is a Single-Sided Deafness (SSD) CI user
• Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor)
• Lack of compliance with any inclusion criteria
• Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ABF fitting followed by standard fitting	Post-operative ABF followed by fitting according to clinical standard	-
Standard fitting followed by ABF fitting	Fitting according to clinical standard followed by post-operative ABF	-

Primary Outcome Measures

Name	Time	Method
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR	8 months post-activation

Secondary Outcome Measures

Name	Time	Method
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)	8 months post- activation
Speech recognition in quiet: Percentage correctly identified phonemes	8 months post-activation
Speech discrimination: Number of correctly discriminated pairs of phonemes	8 months post- activation
Patient reported outcome: Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain	8 months post- activation	The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from "Never" to "Always" (Statement 1-55) or from "No" to "Quite well" (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items. For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome.
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain	8 months post- activation	The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain	6 months post- activation	The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from "Never" to "Always" (Statement 1-55) or from "No" to "Quite well" (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items.For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome.
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit	8 months post- activation	The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussel, Belgium